Six pharma companies are on Santa’s naughty list this Christmas. AstraZeneca, Biogen, Daiichi Sankyo, Lundbeck, Novo Nordisk and UCB have all been hit by the U.K.’s drug marketing regulator the PMCPA.
The latest round of censure also highlights the danger for pharma when it comes to using LinkedIn. The PMPCA works as a self-regulatory body and polices the drug marketing rules set out under the ABPI Code. Depending on the severity of the breach, actions can range from a slap on the wrist to more severe and public punishment.
Novo Nordisk has in this recent cluster of completed cases been singled out for the PMPCA’s harshest punishments in its latest ruling. The diabetes and weight loss specialist may well find coal in its stocking this year. It breached seven clauses of the ABPI Code, including clause 2: bringing discredit upon and reducing confidence in the pharmaceutical industry.
This is the worst clause to break, and the PMCPA and its Appeal Board were so concerned about Novo's behavior that the company has also been publicly reprimanded and reported to the ABPI Board for an audit. Besides kicking a company out of the ABPI, being reported for an audit is the highest level of punishment the PMCPA can make.
So what happened to earn such ire? According to the newly released case report, the issue centers on a LinkedIn post about an obesity webinar training, which turned out to be sponsored by Novo Nordisk. The company markets Saxenda in the U.K., a weight loss drug.
The complainant who brought the case to the PMCPA said that Novo's sponsorship was not clear. The complainant also alleged that the LinkedIn post did not say whether the webinar was a promotional or non-promotional session.
Given that Novo sells Saxenda, the complainant said in the case files that “this appeared to be promotional.” Novo was also covering the costs for patient group directions (known as PGDs), which are written instructions to help healthcare professionals in the U.K. supply or administer medicines to patients.
When assessing the complaint, the PMCPA agreed with the complainant’s concerns. In fact, PMCPA went further, saying that it “was very concerned that Novo Nordisk did not recognize that this was a large-scale Saxenda promotional campaign, which Novo Nordisk knowingly paid for and which was disguised.”
It also found that Novo covering the cost of a PGD “was a benefit being offered to individual health professionals and amounted to an inducement.”
Novo appealed the original ruling but the PMCPA’s Appeal Board kicked it back. The PMCPA said in its case files that it “was concerned about the potential impact on patient safety of providing unbalanced information to a wide audience, particularly given that the arena of weight loss was a highly emotional arena, and particularly given the lack of balance of Saxenda’s safety profile and side effects when comparing it with its competitors.”
AstraZeneca, Biogen, Daiichi Sankyo, Lundbeck and UCB were also all found in breach of clause 2 of the ABPI Code, though they did not get the reprimands that Novo did.
UCB was hit for its promotion of plaque psoriasis drug Bimzelx (bimekizumab) breaching three clauses. UCB did not make the LinkedIn post but “liked” it on the platform. The post was deemed promotional in nature, despite the drug not having an approval at the time. The PMCPA ruled that even by liking the post, UCB had breached its rules.
AstraZeneca, like Novo, was found in breach of seven clauses. The issues include a promotional post by a senior AZ employee on their personal LinkedIn account “and failing to recognize the promotional nature of the post,” according to the PMCPA. The LinkedIn message focused on some new data for its cancer drug Enhertu in a setting it did not have marketing clearance for at the time.
AZ was also hit “for failing to appropriately brief a very senior employee for a press interview” as well as “for failing to ensure that a press release dealing with a sensitive subject complied with relevant requirements of the Code and for failing to notify a newspaper about the potential implications of quotes given the sensitivity of the subject matter,” according to the case files. This centered on an interview in The Times of London, also talking about the Enhertu data, which talked it up as a “cure”.
Biogen was hit with two breaches. A local senior leader, who has since left the company, sent an email to a broad internal audience back in 2018, which linked a fundraising activity with the work that the recipient charities were doing with Biogen in relation to its rare disease drug Spinraza.
The leader was, according to the case files, trying to overturn a rejection for its drug from NICE, England’s drug pricing watchdog which decides whether the country’s taxpayers should pay for a new medicine. The email asked Biogen staffers to contribute to an SMA charity “so that it would have a positive impression and thus it would curry favor and increase the pressure on NICE to reverse the decision,” according to the PMCPA, which agreed with the complainant was bad behavior and ruled it in breach of clause 2 and clause 9.1, failing to maintain high standards.
Japanese cancer drugmaker Daiichi, meanwhile, was in breach of four clauses, including Clause 2, for a misleading claim for its cholesterol drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) that did not clearly state their contraindications with the use with certain doses of another cholesterol drug, namely simvastatin (it was only in a footnote). The PMPCA ruled that this strategy put patients’ safety at risk.
And lastly, we have Lundbeck, which was in breach of four clauses for promoting migraine med Vyepti (eptinezumab) during a symposium but before it had been approved, a big no-no in drug marketing. Like everyone else, Lundbeck also got hit with breaching clause 2 of the code.